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THE CONSENSUS SLEEP DIARY

http://dx.doi.org/10.5665/sleep.1642

The Consensus Sleep Diary: Standardizing Prospective Sleep Self-Monitoring


Colleen E. Carney, PhD1; Daniel J. Buysse, MD2; Sonia Ancoli-Israel, PhD3; Jack D. Edinger, PhD4; Andrew D. Krystal, MD5; Kenneth L. Lichstein, PhD6;
Charles M. Morin, PhD7
1
Ryerson University, Toronto, Canada; 2University of Pittsburgh School of Medicine, Pittsburgh, PA; 3University of California San Diego, La Jolla, CA;
4
Veterans’ Affairs and Duke University Medical Centers, Durham, NC; 5Duke University Medical Center, Durham, NC; 6The University of Alabama,
Tuscaloosa, AL; 7Laval University, Quebec, Canada

Study Objectives: To present an expert consensus, standardized, patient-informed sleep diary.


Methods and Results: Sleep diaries from the original expert panel of 25 attendees of the Pittsburgh Assessment Conference1 were collected
and reviewed. A smaller subset of experts formed a committee and reviewed the compiled diaries. Items deemed essential were included in a
Core sleep diary, and those deemed optional were retained for an expanded diary. Secondly, optional items would be available in other versions. A
draft of the Core and optional versions along with a feedback questionnaire were sent to members of the Pittsburgh Assessment Conference. The
feedback from the group was integrated and the diary drafts were subjected to 6 focus groups composed of good sleepers, people with insomnia,
and people with sleep apnea. The data were summarized into themes and changes to the drafts were made in response to the focus groups. The
resultant draft was evaluated by another focus group and subjected to lexile analyses. The lexile analyses suggested that the Core diary instruc-
tions are at a sixth-grade reading level and the Core diary was written at a third-grade reading level.
Conclusions: The Consensus Sleep Diary was the result of collaborations with insomnia experts and potential users. The adoption of a standard
sleep diary for insomnia will facilitate comparisons across studies and advance the field. The proposed diary is intended as a living document which
still needs to be tested, refined, and validated.
Keywords: Sleep diary, insomnia, sleep assessment
Citation: Carney CE; Buysse DJ; Ancoli-Israel S; Edinger JD; Krystal AD; Lichstein KL; Morin CM. The consensus sleep diary: standardizing pro-
spective sleep self-monitoring. SLEEP 2012;35(2):287-302.

INTRODUCTION estimate treatment effect sizes.5-8 However, these effect size


Insomnia is a very prevalent and significant sleep disorder estimates were based on data from a variety of sleep diaries
associated with reduced quality of life, increased healthcare with distinctive instructional sets and inconsistent definitions
costs, and increased risks for serious psychiatric and medical of target sleep measures.
comorbidities.2,3 Over the past four decades, a bourgeoning Researchers agree that having insomnia sufferers prospec-
body of research has focused on the epidemiology, causes, con- tively self-monitor or record their sleep on a night-by-night
sequences, and treatment of this condition. This research has basis with a sleep diary is a useful methodology for assess-
advanced our understanding of the manifestations and manage- ment and for tracking treatment effects.1,9,10 Moreover, there is
ment of insomnia. Yet, as noted in a previous consensus report,1 agreement that such self-monitoring should yield information
the collective impact of these studies has been limited by a lack about a number of relevant metrics including nightly sleep
of standardization in insomnia research methodologies. This onset latency (SOL), wakefulness after initial sleep onset
lack of standardization, in turn, has contributed to inconsisten- (WASO), total sleep time (TST), total time spent in bed (TIB),
cies in study findings that have hindered our ability to translate sleep efficiency (SE, i.e., the percent of the time asleep out
research findings into clinical practice. of amount of time spent in bed), and sleep quality or satis-
This lack of standardization spilled over to some of the faction, which reflects a subjective global appraisal of each
most basic tools used in insomnia research, such as the sleep night’s sleep. On the other hand, researchers have not agreed
diary. While there is widespread agreement that a sleep di- on the format of the sleep diary. In fact, multiple lab-specific
ary should routinely be included in insomnia research,1 the sleep diaries have emerged, with response formats including
absence of a standardized and widely used sleep diary has numerical sleep/wake estimates, Likert ratings, and visual
compromised the ability to fully interpret and integrate results analogue scales. Diaries also vary as to whether respondents
of previous studies.4 For example, meta-analyses of insomnia were asked to provide estimates of all of the key parameters
treatment studies have primarily relied on sleep diary data to or whether some parameters, such as TST and WASO, were
calculated from other parameters. Finally, researchers have
used various definitions and different calculations for indices
A commentary on this article appears in this issue on page 175. such as SE and WASO (including or not including the final
awakening), the primary measures of interest in many insom-
Submitted for publication March, 2011 nia clinical trials.
Submitted in final revised form June, 2011 Despite the lack of a standardized format, the sleep diary has
Accepted for publication June, 2011 been regarded as the “gold standard” for subjective sleep as-
Address correspondence to: Colleen E. Carney, PhD, Ryerson Univer- sessment. Clearly the adoption of a standard sleep diary would
sity, 350 Victoria Street, JOR807, Toronto, Ontario, Canada M5B 2K3; be a major step toward moving the field forward. Based on
Tel: (416) 979-5000 ext. 2177; Fax: (416) 979-5273; E-mail: ccarney@ these considerations, the development of a standardized, con-
ryerson.ca sensually supported sleep diary is long past due.1
SLEEP, Vol. 35, No. 2, 2012 287 Consensus Sleep Diary—Carney et al
The development of such a diary, however, faces a number of for developing a consensus sleep diary. The group agreed on
challenges. The considerable diversity among the sleep diaries the following decisions concerning the general purpose and for-
used in previous research suggests that there are many differ- mat of the diary to be developed. Additionally, the group agreed
ent points of view about: (1) the range of questions that should upon the method whereby items would be evaluated:
be included and how these questions should be worded; (2) • The Consensus Sleep Diary (CSD) would be developed
how the diary should be formatted; (3) whether the sleep di- primarily for the purposes of insomnia research. Howev-
ary should elicit quantitative responses, qualitative responses, er, the structure of the CSD would also be general enough
or both; (4) how common sleep parameters (SOL, WASO, SE) to be useful for clinical and research applications for all
should be defined; (5) how much data should be acquired on a sleep disorders as well as for good sleepers.
single sleep diary form (one day, one week, two weeks, etc.); • The CSD would build upon sleep diaries previously used
and (6) what time of day respondents should complete diary in insomnia research to facilitate comparisons across past
questions (i.e., in the morning, in the evening or both). Reach- and future studies.
ing consensus among insomnia researchers would be an impor- • Recommendations regarding the CSD from the larger
tant first step. group of insomnia experts who attended the 2005 Pitts-
Qualitative research on the acceptability of the diary by pa- burgh Assessment Conference1 would also be captured.
tients and research subjects would also be important to deter- For example, there would be consistency in the calcula-
mine and has not been carried out for existing diary versions tion of sleep indices described in Buysse et al.1 and in the
(for example, whether they understand the diary questions as new CSD (see Table 1).
intended and if they able to complete the diary easily over • Alternate forms of the CSD would be developed to of-
extended self-monitoring periods without incurring undue fer researchers optimal flexibility in addressing research
burden). Indeed, the U.S. Food and Drug Administration has questions. A “Core” CSD would be developed that includ-
suggested that soliciting patient-reported outcomes (PROs) is ed a standard set of items minimally sufficient for sleep
an important piece in the development and validation of mea- diary-based research while an expanded form would al-
sures to be used in labeling studies.11 Thus, a consensus-based low applications that require tracking daytime data (e.g.,
standardized sleep diary that is also informed by patient/user napping, caffeine use, daytime alertness).
opinion could greatly advance the field. • Previously developed diaries would be solicited from the
Recognizing the challenges these considerations pose, a insomnia research community, including Pittsburgh As-
workgroup was formed to develop and propose a consensus- sessment Conference members, and these diaries would
based standardized sleep diary. The specific aims of this work- be analyzed, compared, and discussed among the CSD
group were to: (1) review the range and nature of sleep diaries Workgroup members to identify those items most com-
previously used in insomnia research; (2) solicit diaries cur- monly used and likely to be supported by the insomnia
rently used from a large group of insomnia researchers; (3) research community.
identify commonalities in previously used sleep diaries and • The Core CSD would be designed to fit on a single
integrate those commonalities into a consensus instrument; (4) 8.5” × 11” page in landscape format, whereas the expand-
solicit critical input about the resultant consensus sleep diary ed CSD version would be designed to fit on the front and
from a wide range of insomnia researchers; (5) conduct qualita- back sides of a single page. This was primarily a practical
tive field testing with patients to acquire additional information solution that was made in order to both save paper and to
to be used for refining the diary instrument and its associated appear less daunting to a diary user.
instructional set; and (6) conduct preliminary lexical analyses • The wording of the diary items would be in past tense
on the reading level required for the measure. since they are most often completed the morning after the
night being reporting upon.
METHODS • All questions would be written in the second person so
The consensus sleep diary project was an outgrowth of the that it would appear as though the researcher/clinician
2005 Insomnia Assessment Conference which resulted in a was inquiring about the sleep behaviors.
publication with recommendations for standard research as- The workgroup then solicited copies of sleep diaries from
sessment of insomnia.1 The original conference was convened all 25 members of the original Pittsburgh Assessment Confer-
in Pittsburgh, PA, and was comprised of an Organizing Com- ence. Items from the submitted diaries were grouped according
mittee (consisting of Daniel J. Buysse, Sonia Ancoli-Israel, to item content and placed together on a worksheet for review.
Jack D. Edinger, Kenneth L. Lichstein, and Charles M. Mo- For example, items that assessed respondents’ estimates of how
rin) and 20 invited insomnia experts selected for their research long it took to initially fall asleep were grouped together. The
contributions to the field of insomnia as well as for their broad worksheet had no indication of the original sources.
representation of different types of insomnia research. Once all sets of items were placed on the worksheet, each
Beginning in 2008, the five members of the organizing com- member of the workgroup rated their top three choices for each
mittee and two additional insomnia researchers (Colleen E. item’s wording. Members were also permitted to suggest new
Carney and Andrew D. Krystal) participated in a workgroup wording if no choices were desirable. For example, if an item set
convened to develop a consensus sleep diary. This workgroup contained no options worded in the past tense or second person,
held a number of conference calls for planning purposes and new items were constructed. The results of the item rating and
then convened for a face-to face meeting in Chicago, IL, on the rewording process were circulated among members, who
April 28-29, 2008 to discuss general objectives and strategies were blind to the identity of the person suggesting the reworded
SLEEP, Vol. 35, No. 2, 2012 288 Consensus Sleep Diary—Carney et al
items. The workgroup then reviewed the results of the item rat- (including the layout) of the CSD items. As the optional ver-
ings and rewording via teleconference and agreed upon the final sions had the same items with differing instructions, only one
wording of each item. In many cases there was a high degree of of the sleep diaries with all optional items (later referred to as
agreement. For cases in which the group was divided about the the Consensus Sleep Diary, Morning administration or CSD-M)
optimal item wording, consensus was achieved through discus- was used. Six focus groups were conducted: two focus groups
sion. The workgroup also discussed whether each item would of good sleepers, two of individuals with insomnia, and two of
be included as part of the Core CSD or remain as an optional sleep apnea patients. Diagnosis was based on self-identifica-
item on the expanded CSD. The results of this teleconference tion. A total of 47 individuals participated (14 good sleepers,
yielded an initial draft of the core and expanded CSD items. 18 with insomnia, 14 with sleep apnea; 53% female; age 18-
The items were then entered into a self-report tabular for- 70 years). Participants were recruited from local sleep clinics,
mat which was discussed on a subsequent teleconference. The research registries, and advertisements. All groups were run at
workgroup agreed to include guidelines for respondents within the University of Pittsburgh by master’s level facilitators with
the diary itself to decrease the likelihood of common mistakes. experience in conducting focus groups for the development of
For instance, the workgroup agreed it was important to include PROs in the NIH-funded PROMIS Roadmap Initiative (U01
indicators for whether a time was AM or PM, denoting whether AR52155). Following a scripted introduction explaining the
the number refers to minutes or hours, and including tick boxes purpose of sleep diaries, each focus group was asked a set of
next to qualitative Likert scale items. A sample column was in- structured questions designed to elicit descriptions of sleep and
cluded to model the desired format of responses. Once the for- daytime activities and events related to sleep. In particular, they
mat was agreed upon, instructions for the diary were written. In were asked how they would describe their sleep in quantita-
formulating these instructions, workgroup members discussed tive terms (e.g., sleep timing, time to fall asleep, sleep amount,
their clinical observations of common pitfalls in completing number and duration of awakenings) and qualitative terms
diaries. For example, some patients/respondents have difficulty (e.g., restfulness, impact of sleep on daytime function). Finally,
ascertaining if diary questions pertain to the previous or en- each group was shown the proposed sleep diary, and asked for
suing night. It was agreed that the instructions needed to be their comments regarding its utility, format, and adequacy for
explicit and written at or below an eighth-grade reading level. describing their sleep.
The first author (CEC) then drafted a set of instructions for the The facilitator and a co-facilitator each took notes and devel-
diaries and circulated them for the other members to discuss in oped a set of summary comments for each group. These notes
a subsequent teleconference on which the instructions were fur- and summary comments were reviewed by the CSD workgroup
ther revised to ensure they were sufficiently clear. The reading along with an external consultant with expertise in focus group
level tool in Microsoft Office 2007 Word was used to determine methodology (Dr. Kelly E. McShane), which resulted in a set of
the reading level. major themes. A preliminary review of participants’ comments
Draft versions of the core and expanded (i.e., optional items) from the first five groups led to modifications in the sample
CSD along with their instructional sets were then circulated to CSD diary presented to the final group, which consisted of
the 2005 Pittsburgh Assessment Conference members for feed- sleep apnea patients.
back. In addition to the CSD and instructions, a questionnaire
was also included. The diaries and instructions were re-edited Lexile Analysis
based on the responses. The workgroup then conducted qualita- The core CSD as well as the expanded, optional version (later
tive research with potential respondents’ focus groups. referred to as CSD-M) of the sleep diary and the instruction sets
were both submitted to lexile analysis (http://www.lexile.com/
Focus Groups: Rationale and Procedures analyzer/), which takes into account both the semantic (word
Previous research on focus groups suggested that obtaining frequency) and syntactic (sentence length) characteristics of the
participant input via methods such as focus groups is a crucial writing sample resulting in a lexile score corresponding to spe-
component of developing patient reported outcomes (PRO).11,12 cific reading grade levels.18,19
Focus groups were therefore conducted to evaluate the core and
expanded CSD to ensure that the PRO items actually measured RESULTS
the constructs and phenomena relevant to the insomnia patient The solicitation of sleep diaries versions from the 25 mem-
or subject. bers of the original Pittsburgh Assessment Conference yielded
In general, focus groups consist of small groups of people replies from 22 members (88% response rate). Three members
who are asked in general terms about their perceptions, opin- did not respond to multiple contact attempts. Of the 22 sleep
ions, beliefs, and attitudes towards methods for evaluating diaries that were submitted, only 16 were unique, as some ver-
the construct in question. Specifically, focus group discus- sions were in use across more than one site.
sions help the research team discover the vocabulary and There were seven replies (35%) to the request for clini-
the thinking patterns of the target group in a format that en- cian feedback on the initial draft of the consensus sleep di-
courages free communication. Although the results of focus ary. The first four questions of the questionnaire were Likert
groups can be described in quantitative terms, they are best scale items (rated from 0 = not at all understandable to 3
viewed as hypothesis-generating rather than hypothesis-test- = very understandable) that asked: (1) Are the instructions
ing procedures.15-17 clear? (mean 3; SD = 0); (2) Are the Core items clear? (mean
The goal of the CSD focus groups was to solicit participant 3; SD = 0); (3) Is the Core diary format clear? (mean 2.8;
opinions regarding the optimal content, wording, and format SD = 0.45); (4) Is the Optional diary format clear? (mean 2.6;
SLEEP, Vol. 35, No. 2, 2012 289 Consensus Sleep Diary—Carney et al
SD = 0.55). The next question asked: (5) Should the diary in- Findings from Focus Groups
clude both evening and morning sections? Of those respond-
ing, 50% reported there should be an option for completing Participants’ responses to the CSD
some items at night, 33% reported that evening completion Upon reviewing the draft version of the CSD-M, participants
should not be an option, and 17% reported that this option offered a variety of opinions regarding alternative format and
should be available for asking about daytime functioning layouts. Some participants suggested that alternate graphical
only, e.g. naps, energy, mood. The last question asked: (6) formats, such as clock faces or time charts, would be more
Was there something we missed? Over half (57%) approved useful. Some advocated electronic formats, such as hand-held
of the CSD in its initial format. One respondent requested or desktop computer-based. In general, participants found the
the addition of an adherence item (e.g., whether the person initial version to be too cluttered, the print too small, and ad-
was following a treatment recommendation such as stimulus vocated larger check boxes and less pre-printed text in the re-
control); however, it was decided not to include this item as sponse areas. Several participants among both good sleepers
it was only relevant for treatment trials. Another suggestion and insomnia groups found the diary to be too complicated and
was to include direct estimate of TST as a Core rather than “overwhelming,” and would have preferred a single-day for-
optional item; however the decision was made to derive this mat. Most importantly, participants expressed it was important
variable from other information in the diary, as recommended to include some method for adding comments regarding impor-
by Buysse et al.1 tant influences on a particular night of sleep. As a result of these
Three versions of the final consensus sleep diary were cre- comments, the sleep diary format was modified by eliminating
ated and are shown in Figures 1-3. blank lines to fill in times, a.m./p.m. check boxes, and text with
The Core Consensus Sleep Diary: The CSD (Figure 1) con- units that followed participant responses (e.g., minutes, hours).
tained 9 items considered by the CSD workgroup and the 2005 A “Comments” field was added for respondents to describe im-
conference participants to represent the most critical param- portant qualitative and experiential aspects of sleep. The final
eters. The questions ask about: (1) the time of getting into bed; focus group (in sleep apnea patients) agreed that the new form
(2) the time at which the individual attempted to fall asleep; (3) was less cluttered, but still commented that the proposed format
sleep onset latency; (4) number of awakenings; (5) duration of left little opportunity to describe specific aspects of sleep.
awakenings; (6) time of final awakening; (7) final rise time; (8)
perceived sleep quality (rated via Likert scale); and (9) an ad- Participants’ description of sleep
ditional space for open-ended comments from the respondent. When asked how a sleep diary could best summarize quan-
As previously agreed upon, the core CSD was formatted so that titative aspects of their sleep, participants recommended sleep
one week of nightly sleep data could be recorded on a single latency, sleep duration, and number and duration of awaken-
diary page. The CSD instructions included general information, ings. However, a variety of suggestions on how best to capture
such as what to do if the respondent misses recording on a par- that information were given. A number of participants suggest-
ticular day, and item-specific instructions to enhance likelihood ed that numerical estimates would be only crude representa-
of correct item interpretation. For example, the instructions for tions of their experience. Several participants suggested that the
item #6 tell the respondent to record the time of the final awak- longest “solid” sleep period was an important quantitative as-
ening in the morning. The additional instructions indicate that pect of sleep. When asked about how to document other, more
all of the items are to be completed in the morning within one qualitative aspects of sleep, participants gave a wide variety of
hour of getting out of bed. responses reflecting their individual experiences. For instance,
The Expanded Consensus Sleep Diary for Morning: An ex- different participants emphasized elements such as the lightness
panded version of the CSD (Figure 2) included a number of or deepness of sleep, dream experiences, effects of physical
optional items that could be completed in the morning upon symptoms and medications, and the influence of environmen-
arising (Optional morning completion items – CSD-M). The tal and emotional factors on sleep. In a similar fashion, par-
CSD-M includes additional items about early (premature) ticipants described the relationship between sleep and waking
morning awakenings (EMA), estimated total sleep time, Likert experiences in a variety of personal ways, including effects on
scale rating of the refreshing quality of sleep, napping/dozing, cognitive, physical, and emotional well-being, as well as effects
and alcohol, caffeine, and medication use. The instructions for of alertness and napping behavior. The bidirectional nature of
the additional questions in CSD-M also stipulate that the diary waking and sleep experiences was a common theme for many
should be completed in the morning. participants. The most consistent overall theme was the need to
The Expanded Consensus Sleep Diary for Evening: A third express personalized comments regarding sleep and wakeful-
version of the CSD included the same items as CSD-M, but ness. Participants reported that any brief quantitative summary
with instructions for morning and evening completion (Option- was inadequate to describe their sleep experience, and that it
al morning and evening completion – CSD-E; Figure 3). The was important to be able to describe their sleep experience in
morning and evening items in the CSD-E are grouped separate- some detail. This theme can be seen as a commentary on inter-
ly. The instructions stipulated that items about daytime activity actions regarding sleep with health care providers in general,
such as caffeine, alcohol, and medication use or napping which beyond what a sleep diary is able to capture.
appear on one side of the diary are to be completed at night be-
fore going to bed, while the remaining items which appear on Lexile Analysis
the other side and query about the previous night’s sleep are to For the CSD-Core, mean sentence length was 8.2 words (SD
be completed the following morning. 2.7, range 3-12), and mean lexile Measure was 441 (SD = 185.9,
SLEEP, Vol. 35, No. 2, 2012 290 Consensus Sleep Diary—Carney et al
Figure 1

Sleep Diary Instructions - Core

General Instructions

What is a Sleep Diary? A sleep diary is designed to gather information about your daily sleep pattern.

How often and when do I fill out the sleep diary? It is necessary for you to complete your sleep diary every day. If
possible, the sleep diary should be completed within one hour of getting out of bed in the morning.

What should I do if I miss a day? If you forget to fill in the diary or are unable to finish it, leave the diary blank for
that day.

What if something unusual affects my sleep or how I feel in the daytime? If your sleep or daytime functioning is
affected by some unusual event (such as an illness, or an emergency) you may make brief notes on your diary.

What do the words “bed” and “day” mean on the diary? This diary can be used for people who are awake or
asleep at unusual times. In the sleep diary, the word “day” is the time when you choose or are required to be awake.
The term “bed” means the place where you usually sleep.

Will answering these questions about my sleep keep me awake? This is not usually a problem. You should not
worry about giving exact times, and you should not watch the clock. Just give your best estimate.

Item Instructions

Use the guide below to clarify what is being asked for each item of the Sleep Diary.
Date: Write the date of the morning you are filling out the diary.
1. What time did you get into bed? Write the time that you got into bed. This may not be the time that
you began “trying” to fall asleep.
2. What time did you try to go to sleep? Record the time that you began “trying” to fall asleep.
3. How long did it take you to fall asleep? Beginning at the time you wrote in question 2, how long did
it take you to fall asleep.
4. How many times did you wake up, not counting your final awakening? How many times did you
wake up between the time you first fell asleep and your final awakening?
5. In total, how long did these awakenings last? What was the total time you were awake between the
time you first fell asleep and your final awakening. For example, if you woke 3 times for 20 minutes, 35
minutes, and 15 minutes, add them all up (20+35+15= 70 min or 1 hr and 10 min).
6. What time was your final awakening? Record the last time you woke up in the morning.
7. What time did you get out of bed for the day? What time did you get out of bed with no further
attempt at sleeping? This may be different from your final awakening time (e.g. you may have woken
up at 6:35 a.m. but did not get out of bed to start your day until 7:20 a.m.)
8. How would you rate the quality of your sleep? “Sleep Quality” is your sense of whether your sleep
was good or poor.
9. Comments If you have anything that you would like to say that is relevant to your sleep feel free to
write it here.

Figure 1—Sleep Diary Instructions: Core Figure 1 continues on the following page

range 230-880), corresponding to a third-grade reading level morning (CSD-M), and the other version has some items com-
(range second-seventh grade). For CSD-Core diary instructions, pleted in the morning and other items that are completed before
mean sentence length was 13.6 words (SD 5.5, range 5-27), with bed). Thus, these two versions have the same wording so only
a mean lexile Measure of 755.2 (SD 334.6, range 80-1500), cor- the CSD-M was examined. For CSD-M, mean sentence length
responding to a mean sixth-grade reading level (range less than was 9.2 words (SD 2.5, range 5-14), and mean lexile Measure
first grade to post-high school). The two optional versions only was 555 (SD 255, range 160-1040), corresponding to a third-
differ on the format of the diary. That is, they are completed grade reading level (range first-eighth grade). For the CSD-M
at two different times; one version is completed entirely in the instructions, mean sentence length was 12.3 words (SD 5.3,
SLEEP, Vol. 35, No. 2, 2012 291 Consensus Sleep Diary—Carney et al
Consensus Sleep Diary—Carney et al
Consensus Sleep Diary-Core ID/Name:________________________________
Sample
Today’s date 4/5/11
1. What time did
you get into bed?
10:15 p.m.
2. What time did
you try to go to 11:30 p.m.
sleep?
3. How long did it
take you to fall 55 min.
asleep?
4. How many
times did you
wake up, not 3 times
counting your final
awakening?
5. In total, how

292
1 hour
long did these
awakenings last? 10 min.
6. What time was 6:35 a.m.
your final
awakening?

Figure 1 (continued)—Sleep Diary Instructions: Core


7. What time did 7:20 a.m.
you get out of bed
for the day?
8. How would you □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor
rate the quality of  Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor
your sleep? □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair

SLEEP, Vol. 35, No. 2, 2012


□ Good □ Good □ Good □ Good □ Good □ Good □ Good □ Good
□ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good
9. Comments
(if applicable)
I have a cold
Sleep Diary Instructions (CSD-M)

General Instructions

What is a Sleep Diary? A sleep diary is designed to gather information about your daily sleep pattern.

How often and when do I fill out the sleep diary? It is necessary for you to complete your sleep diary
every day. If possible, the sleep diary should be completed within one hour of getting out of bed in the
morning.

What should I do if I miss a day? If you forget to fill in the diary or are unable to finish it, leave the
diary blank for that day.

What if something unusual affects my sleep or how I feel in the daytime? If your sleep or daytime
functioning is affected by some unusual event (such as an illness, or an emergency) you may make
brief notes on your diary.

What do the words “bed” and “day” mean on the diary? This diary can be used for people who are
awake or asleep at unusual times. In the sleep diary, the word “day” is the time when you choose or
are required to be awake. The term “bed” means the place where you usually sleep.

Will answering these questions about my sleep keep me awake? This is not usually a problem.
You should not worry about giving exact times, and you should not watch the clock. Just give your best
estimate.

Sleep Diary Item Instructions

Use the guide below to clarify what is being asked for each item of the Sleep Diary.
Date.: Write the date of the morning you are filling out the diary.
1. What time did you get into bed? Write the time that you got into bed. This may not be the time you
began “trying” to fall asleep.
2. What time did you try to go to sleep? Record the time that you began “trying” to fall asleep.
3. How long did it take you to fall asleep? Beginning at the time you wrote in question 2, how long did it
take you to fall asleep.
4. How many times did you wake up, not counting your final awakening? How many times did you wake
up between the time you first fell asleep and your final awakening?
5. In total, how long did these awakenings last? What was the total time you were awake between the
time you first fell asleep and your final awakening. For example, if you woke 3 times for 20 minutes, 35
minutes, and 15 minutes, add them all up (20+35+15= 70 min or 1 hr and 10 min).
6a. What time was your final awakening? Record the last time you woke up in the morning.
6b. After your final awakening, how long did you spend in bed trying to sleep? After the last time you woke-up
(Item #6a), how many minutes did you spend in bed trying to sleep? For example, if you woke up at 8 am but
continued to try and sleep until 9 am, record 1 hour.
6c. Did you wake up earlier than you planned? If you woke up or were awakened earlier than you
planned, check yes. If you woke up at your planned time, check no.
6d. If yes, how much earlier? If you answered “yes” to question 6c, write the number of minutes you
woke up earlier than you had planned on waking up. For example, if you woke up 15 minutes before

Figure 2 continues on the following page

Figure 2—Sleep Diary Instructions (CSD-M)

SLEEP, Vol. 35, No. 2, 2012 293 Consensus Sleep Diary—Carney et al


the alarm went off, record 15 minutes here.
7. What time did you get out of bed for the day? What time did you get out of bed with no further
attempt at sleeping? This may be different from your final awakening time (e.g. you may have woken
up at 6:35 a.m. but did not get out of bed to start your day until 7:20 a.m.)
8. In total, how long did you sleep? This should just be your best estimate, based on when you went to
bed and woke up, how long it took you to fall asleep, and how long you were awake. You do not need
to calculate this by adding and subtracting; just give your best estimate.
9. How would you rate the quality of your sleep? “Sleep Quality” is your sense of whether your sleep
was good or poor.
10. How restful or refreshed did you feel when you woke up for the day? This refers to how you felt
after you were done sleeping for the night, during the first few minutes that you were awake.
11a. How many times did you nap or doze? A nap is a time you decided to sleep during the day,
whether in bed or not in bed. “Dozing” is a time you may have nodded off for a few minutes, without
meaning to, such as while watching TV. Count all the times you napped or dozed at any time from
when you first got out of bed in the morning until you got into bed again at night.
11b. In total, how long did you nap or doze? Estimate the total amount of time you spent napping or
dozing, in hours and minutes. For instance, if you napped twice, once for 30 minutes and once for 60
minutes, and dozed for 10 minutes, you would answer “1 hour 40 minutes.” If you did not nap or doze,
write “N/A” (not applicable).
12a. How many drinks containing alcohol did you have? Enter the number of alcoholic drinks you had
where 1 drink is defined as one 12 oz beer (can), 5 oz wine, or 1.5 oz liquor (one shot).
12b. What time was your last drink? If you had an alcoholic drink yesterday, enter the time of day in
hours and minutes of your last drink. If you did not have a drink, write “N/A” (not applicable).
13a. How many caffeinated drinks (coffee, tea, soda, energy drinks) did you have? Enter the number of
caffeinated drinks (coffee, tea, soda, energy drinks) you had where for coffee and tea, one drink = 6-8
oz; while for caffeinated soda one drink = 12 oz.
13b. What time was your last caffeinated drink? If you had a caffeinated drink, enter the time of day in
hours and minutes of your last drink. If you did not have a caffeinated drink, write “N/A” (not
applicable).
14. Did you take any over-the-counter or prescription medication(s) to help you sleep? If so, list
medication(s), dose, and time taken: List the medication name, how much and when you took EACH
different medication you took tonight to help you sleep. Include medication available over the counter,
prescription medications, and herbals (example: "Sleepwell 50 mg 11 pm"). If every night is the same,
write “same” after the first day
15. Comments: If you have anything that you would like to say that is relevant to your sleep feel free to
write it here.

Figure 2 (continued)—Sleep Diary Instructions (CSD-M) Figure 2 continues on the following page

range 5-24), with a mean lexile Measure of 702 (SD 341, range search studies has posed a significant impediment to progress
30-1440), corresponding to a mean fourth-grade reading level in the field.1 The development of a Consensus Sleep Diary
(range less than first grade to post-high school). addressed this concern.
Advantages of the CSD in particular include the use of
DISCUSSION both expert consensus and qualitative patient input, as recom-
A consensus sleep diary, based on input from a large mended for development of reliable and valid patient-report
group of insomnia experts and on focus groups of individu- instruments.20 This methodology included collecting and incor-
als with and without sleep disorders, was developed. Sleep porating diaries currently in use in the field, consensus group
diaries have been universally used as the preferred method editing and composing of items, employing focus groups to so-
for collecting data over time on self-reported sleep and re- licit input of subjects/patients both for diary development and
lated function in insomnia research.1,9,10 However, the lack for editing, solicitation of feedback from experts in the insom-
of standardization in diaries currently used in insomnia re- nia research community, and carrying out lexile analysis.
SLEEP, Vol. 35, No. 2, 2012 294 Consensus Sleep Diary—Carney et al
Consensus Sleep Diary—Carney et al
Figure 2 continues on the following page
Consensus Sleep Diary-M (Please Complete Upon Awakening) ID/NAME: ______________________
Sample
Today’s Date 4/5/11
1. What time did you get
10:15 p.m.
into bed?
2. What time did you try
11:30 p.m.
to go to sleep?
3. How long did it take
55 min.
you to fall asleep?
4. How many times did
you wake up, not
6 times
counting your final
awakening?
5. In total, how long did 2 hours
these awakenings last? 5 min.
6a. What time was your
6:35 a.m.
final awakening?
6b. After your final
awakening, how long did 45 min.
you spend in bed trying
to sleep?

295
6c. Did you wake up
earlier than you  Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No
planned?
6d. If yes, how much
1 hour
earlier?
7. What time did you get
7:20 a.m.
out of bed for the day?
8. In total, how long did

Figure 2 (continued)—Sleep Diary Instructions (CSD-M)


4 hours 10 min.
you sleep?
9. How would you rate □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor
the quality of your sleep?  Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor
□ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair
□ Good □ Good □ Good □ Good □ Good □ Good □ Good □ Good
□ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good
10. How rested or □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all
refreshed did you feel rested rested rested rested rested rested rested rested

SLEEP, Vol. 35, No. 2, 2012


when you woke-up for  Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly
the day? rested rested rested rested rested rested rested rested
□ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat
rested rested rested rested rested rested rested rested
□ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested
□ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well-
rested rested rested rested rested rested rested rested
Consensus Sleep Diary—Carney et al
Consensus Sleep Diary-M Continued ID/NAME: _______________________
Sample
Today’s Date 4/5/11
11a. How many
times did you nap or
2 times
doze?
11b. In total, how 1 hour
long did you nap or 10 min.
doze?
12a. How many
drinks containing 3 drinks
alcohol did you
have?
12b. What time was 9 :20 p.m.
your last drink?
13a. How many
caffeinated drinks
(coffee, tea, soda, 2 drinks

296
energy drinks) did
you have?
13b. What time was
3 :00 p.m.
your last drink?
14. Did you take any
over-the-counter or  Yes □ No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No
prescription Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s):

Figure 2 (continued)—Sleep Diary Instructions (CSD-M)


medication(s) to help
you sleep? Relaxo-Herb
Dose: Dose: Dose: Dose: Dose: Dose: Dose: Dose:
If so, list
50 mg
medication(s), dose,
and time taken Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken:
11 pm

SLEEP, Vol. 35, No. 2, 2012


15. Comments
(if applicable)
I have a cold
Sleep Diary Instructions (CSD-E)

General Instructions

What is a Sleep Diary? A sleep diary is designed to gather information about your daily sleep pattern.

How often and when do I fill out the sleep diary? It is necessary for you to complete your sleep diary every
day. If possible, the sleep diary should be completed within one hour of getting out of bed in the morning. The
Nighttime Sleep Diary questions can be completed before you go to bed at night.

What should I do if I miss a day? If you forget to fill in the diary or are unable to finish it, leave the diary blank
for that day.

What if something unusual affects my sleep or how I feel in the daytime? If your sleep or daytime
functioning is affected by some unusual event (such as an illness, or an emergency) you may make brief notes
on your diary.

What do the words “bed” and “day” mean on the diary? This diary can be used for people who are awake or
asleep at unusual times. In the sleep diary, the word “day” is the time when you choose or are required to be
awake. The term “bed” means the place where you usually sleep.

Will answering these questions about my sleep keep me awake? This is not usually a problem. You should
not worry about giving exact times, and you should not watch the clock. Just give your best estimate.

Morning Sleep Diary Item Instructions

Use the guide below to clarify what is being asked for each item of the Sleep Diary.
Date: Write the date of the morning you are filling out the diary.
1. What time did you get into bed? Write the time that you got into bed. This may not be the time you
began “trying” to fall asleep.
2. What time did you try to go to sleep? Record the time that you began “trying” to fall asleep.
3. How long did it take you to fall asleep? Beginning at the time you wrote in question 2, how long did it
take you to fall asleep.
4. How many times did you wake up, not counting your final awakening? How many times did you wake up
between the time you first fell asleep and your final awakening?
5. In total, how long did these awakenings last? What was the total time you were awake between the
time you first fell asleep and your final awakening. For example, if you woke 3 times for 20 minutes, 35
minutes, and 15 minutes, add them all up (20+35+15= 70 min or 1 hr and 10 min).
6a. What time was your final awakening? Record the last time you woke up in the morning.
6b. After your final awakening, how long did you spend in bed trying to sleep? After the last time you woke-up
(Item #6a), how many minutes did you spend in bed trying to sleep? For example, if you woke up at 8 am but
continued to try and sleep until 9 am, record 1 hour.
6c. Did you wake up earlier than you planned? If you woke up or were awakened earlier than you planned,
check yes. If you woke up at your planned time, check no.
6d. If yes, how much earlier? If you answered “yes” to question 6c, write the number of minutes you woke
up earlier than you had planned on waking up. For example, if you woke up 15 minutes before the alarm
went off, record 15 minutes here.
Figure 3 continues on the following page

Figure 3—Sleep Diary Instructions (CSD-E)

SLEEP, Vol. 35, No. 2, 2012 297 Consensus Sleep Diary—Carney et al


7. What time did you get out of bed for the day? What time did you get out of bed with no further
attempt at sleeping? This may be different from your final awakening time (e.g. you may have woken up
at 6:35 a.m. but did not get out of bed to start your day until 7:20 a.m.)
8. In total, how long did you sleep? This should just be your best estimate, based on when you went to
bed and woke up, how long it took you to fall asleep, and how long you were awake. You do not need
to calculate this by adding and subtracting; just give your best estimate.
9. How would you rate the quality of your sleep? “Sleep Quality” is your sense of whether your sleep
was good or poor.
10. How restful or refreshed did you feel when you woke up for the day? This refers to how you felt after
you were done sleeping for the night, during the first few minutes that you were awake.

Nighttime Sleep Diary Item Instructions


Please complete the following items before you go to bed.
Date: Write the date of the evening you are filling out the diary.
11a. How many times did you nap or doze? A nap is a time you decided to sleep during the day,
whether in bed or not in bed. “Dozing” is a time you may have nodded off for a few minutes, without
meaning to, such as while watching TV. Count all the times you napped or dozed at any time from
when you first got out of bed in the morning until you got into bed again at night.
11b. In total, how long did you nap or doze? Estimate the total amount of time you spent napping or
dozing, in hours and minutes. For instance, if you napped twice, once for 30 minutes and once for 60
minutes, and dozed for 10 minutes, you would answer “1 hour 40 minutes.” If you did not nap or doze,
write “N/A” (not applicable).
12a. How many drinks containing alcohol did you have? Enter the number of alcoholic drinks you had
where 1 drink is defined as one 12 oz beer (can), 5 oz wine, or 1.5 oz liquor (one shot).
12b. What time was your last drink? If you had an alcoholic drink yesterday, enter the time of day in
hours and minutes of your last drink. If you did not have a drink, write “N/A” (not applicable).
13a. How many caffeinated drinks (coffee, tea, soda, energy drinks) did you have? Enter the number
of caffeinated drinks (coffee, tea, soda, energy drinks) you had where for coffee and tea, one drink =
6-8 oz; while for caffeinated soda one drink = 12 oz.
13b. What time was your last drink? If you had a caffeinated drink, enter the time of day in hours and
minutes of your last drink. If you did not have a caffeinated drink, write “N/A” (not applicable).
14. Did you take any over-the-counter or prescription medication(s) to help you sleep? If so, list
medication(s), dose, and time taken: List the medication name, how much and when you took EACH
different medication you took tonight to help you sleep. Include medication available over the counter,
prescription medications, and herbals (example: "Sleepwell 50 mg 11 pm"). If every night is the same,
write “same” after the first day
15. Comments If you have anything that you would like to say that is relevant to your sleep feel free to
write it here.

Figure 3 (continued)—Sleep Diary Instructions (CSD-E) Figure 3 continues on the following page

The process of developing the CSD also provided new infor- Beyond the consensus core items, a variety of optional items
mation about sleep diaries and about how people conceptual- were proposed, reflecting the varying aims and constraints of
ize their sleep. Among the leading insomnia experts in the field research studies, the different contexts in which the diary was
consulted, 16 unique sleep diaries were being used and these anticipated to see application, and the specific preferences of
varied in terms of the items included, in the item formats used individual investigators. Further, subjects/patients were in
and in their layout. After considering these and other possibili- agreement on the quantitative dimensions of their sleep that
ties it was possible to reach consensus on core diary items, their they considered to be important, and this was reflected in the
format, and layout as manifested in the final version of the CSD. items included in the final CSD. However, participants/patients
SLEEP, Vol. 35, No. 2, 2012 298 Consensus Sleep Diary—Carney et al
Consensus Sleep Diary—Carney et al
Figure 3 continues on the following page
Consensus Sleep Diary - E (Please Complete Upon Awakening) ID/NAME: ____________________________
Sample
Today’s Date 4/5/11
1. What time did you get
10:15 p.m.
into bed?
2. What time did you try
11:30 p.m.
to go to sleep?
3. How long did it take
55 min.
you to fall asleep?
4. How many times did
you wake up, not
6 times
counting your final
awakening?
5. In total, how long did 2 hours
these awakenings last? 5 min.
6a. What time was your
6:35 a.m.
final awakening?
6b. After your final
awakening, how long did 45 min.
you spend in bed trying
to sleep?

299
6c. Did you wake up
earlier than you  Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No □ Yes □ No
planned?
6d. If yes, how much
1 hour
earlier?
7. What time did you get
7:20 a.m.
out of bed for the day?
8. In total, how long did

Figure 3 (continued)—Sleep Diary Instructions (CSD-E)


4 hours 10 min.
you sleep?
9. How would you rate □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor □ Very poor
the quality of your sleep?  Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor □ Poor
□ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair □ Fair
□ Good □ Good □ Good □ Good □ Good □ Good □ Good □ Good
□ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good □ Very good
10. How rested or □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all □ Not at all
refreshed did you feel rested rested rested rested rested rested rested rested

SLEEP, Vol. 35, No. 2, 2012


when you woke-up for  Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly □ Slightly
the day? rested rested rested rested rested rested rested rested
□ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat □ Somewhat
rested rested rested rested rested rested rested rested
□ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested □ Well-rested
□ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well- □ Very well-
rested rested rested rested rested rested rested rested
Consensus Sleep Diary—Carney et al
Consensus Sleep Diary - E (Please Complete Before Bed) ID/NAME: _________________________
Sample
Today’s Date 4/4/11
11a. How many
times did you nap or
2 times
doze?
11b. In total, how 1 hour
long did you nap or 10 min.
doze?
12a. How many
drinks containing 3 drinks
alcohol did you
have?
12b. What time was 9 :20 p.m.
your last drink?
13a. How many
caffeinated drinks
(coffee, tea, soda, 2 drinks

300
energy drinks) did
you have?
13b. What time was
3 :00 p.m.
your last drink?
14. Did you take any
over-the-counter or  Yes □ No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No □Yes □No
prescription Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s): Medication(s):

Figure 3 (continued)—Sleep Diary Instructions (CSD-E)


medication(s) to help
you sleep? Relaxo-Herb
Dose: Dose: Dose: Dose: Dose: Dose: Dose: Dose:
If so, list
50 mg
medication(s), dose,
and time taken Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken: Time(s) taken:
11 pm

SLEEP, Vol. 35, No. 2, 2012


15. Comments
(if applicable)
I have a cold
also felt that the diary format limited their ability to adequately perception of sleep in a sleep diary is a unique and valued per-
convey the entirety of their sleep experience, and they advocat- spective, and thus, might not necessarily be expected to agree
ed for additional means to describe these experiences. Thus, the with objective measures (e.g., PSG, actigraphy). Despite the
CSD and other diaries should be seen as providing information fact that sleep diaries are widely used in clinical and research
about some, but not all, patient-relevant aspects of sleep. This settings, with few exceptions,23 almost no formal reliability and
theme could be seen as a commentary on interactions regarding validity data have been presented. One of the reasons for the
sleep with health care providers in general, beyond what a sleep paucity of data may relate to the unique challenges mentioned
diary is able to capture. Sleep diaries must be augmented with above. Although the CSD is unique in that it is the first diary to
other tools such as other patient-reported outcome instruments be developed with rigorous methodology for patient-reported
and clinical tools where a broader assessment of sleep is need- outcome development, devising creative ways to evaluate the
ed. The focus group data also suggested that many individuals reliability and validity appropriately will be an important next
prefer alternative formats for sleep data representation (clock step towards the goal of standardizing sleep diary assessment in
faces, time lines). Although the consensus of the group dictated insomnia research and practice.
against employing these formats in the core diary, such alterna-
tive formats could be considered for specific applications. ACKNOWLEDGMENTS
In summary, focus group participants clearly indicated The authors acknowledge the participation of the members
agreement between the quantitative dimensions of sleep they of the original Pittsburgh Assessment Conference in this proj-
considered to be important and those included in the diary. ect: Drs. Celyne Bastien, Ruth Benca, Michael Bonnet, Rich-
However, participants also advocated for a more nuanced and ard Bootzin, Christopher Drake, Colin Espie, Leah Friedman,
experiential description of sleep. In clinical and research set- Goran Hajak, Allison Harvey, Peter Hauri, Kevin Morgan,
tings, these more qualitative aspects of sleep and wakefulness Michael Perlis, Dieter Riemann, Arthur Spielman, Edward
may be captured by other more efficient methods such as spe- Stepanski, Alexandros Vgontzas, James Walsh, and William
cific patient-reported outcomes or clinical interviews. Finally, Wohlgemuth. The authors also thank Melissa Shableski-Cade
multiple participants advocated a more “visual” approach to for her invaluable work in coordinating this project and format-
quantification of sleep (clock faces, time lines) and requested ting the diaries; the members of the PROMIS research team at
simpler formats. Developing alternate methods for administra- the University of Pittsburgh for conducting the focus groups;
tion of the CSD (e.g., electronic versions, single-day formats) and Dr. Kelly E. McShane, Ryerson University for her expertise
may be useful to match the preferences of specific respondents. in extracting qualitative themes from the focus group data.
The CSD presented in this document represents a critical Additional support from MH24652, AG00972, and AG26177
first step in the process of standardizing a sleep diary for use (DJB); AG08415, CA112035, UL1RR031980, the UCSD Stein
across a wide-range of research and clinical applications. It is Institute for Research on Aging and the Department of Veter-
important that additional work investigate the reliability and ans Affairs Center of Excellence for Stress and Mental Health
validity of this instrument. There are some inherent challenges (CESAMH) (SAI); MH67057, HL-073259 and Department of
in establishing reliability and validity with conventional psy- Veterans Affairs IIR-00-091 (JDE); AG14738 and DA13574
chometric analyses. For example, one way of assessing reliabil- (KLL); and MH60413 and Canadian Institutes of Health Re-
ity is to carry out diary assessments in the same individuals at search MT42504 (CMM).
two or more time points; this establishes test-retest reliability.
However, because sleep is known to be highly variable across DISCLOSURE STATEMENT
nights, it may violate the constancy (i.e., temporal stability) as- The 2005 Pittsburgh conference and manuscript preparation
sumption of test-retest reliability.21 A valid assessment of test- were supported by an educational grant from the National Insti-
retest reliability for a sleep diary would likely require many tute of Mental Health; by unrestricted educational grants from
nights to overcome the problem of instability in sleep itself.22 Pfizer, Inc; Sanofi-Aventis, Sepracor, Inc; Takeda Pharmaceu-
Other reliability indices assess the internal consistency of the ticals; and by The Mental Health Intervention Research Center
measure; however, the sleep diary is not intended to measure at the University of Pittsburgh (MH30915). Industry sponsors
one construct, and items are not expected to correlate with one did not contribute to CSD conference planning, nor did they
another (e.g., there is no reason to expect that bed time would participate in any aspect of manuscript preparation. Dr. Carney
correlate with number of awakenings). One possibility is to fo- has no conflicts of interest to report. Dr. Buysse has served as a
cus on the validity of the diary. Construct validity was explored consultant (for less than $10,000 in fees) for the following com-
in the current project via user/focus group feedback and expert panies: Actelion, Cephalon, Eisai, Eli Lilly, GlaxoSmithKline,
feedback (both within and outside the Consensus workgroup). Merck, Neurocrine, Neurogen, Pfizer, Philips, Purdue Pharma,
It would be helpful to have more exploration of the construct L.P., Sanofi-Aventis, Sepracor/Sunovion, Somnus Therapeu-
validity of the CSD. For example, future studies could compare tics, Takeda, and Transcept Pharmaceuticals Inc. Dr. Buysse
the diary data across groups in which the diagnosis has been es- has helped produce CME materials and lectures indirectly sup-
tablished according to clinical diagnostic criteria (e.g., healthy ported by Sanofi-Aventis, Sepracor/Sunovion and Takeda, and
controls, insomnia patients, other groups of interest). One could has been paid for lectures at non-CME educational meetings by
also establish the convergent validity of the CSD by compar- Servier. Dr. Ancoli-Israel has served on the following Consul-
ing CSD data with data derived from other means of assessing tant/Scientific Advisory Boards (for less than $10,000 in fees):
sleep such as polysomnography (PSG), actigraphy, and other Ferring Pharmaceuticals Inc., GlaxoSmithKline, Johnson &
self-report instruments. However, the prospective subjective Johnson, Merck, NeuroVigil, Inc., Pfizer, Philips, Purdue Phar-
SLEEP, Vol. 35, No. 2, 2012 301 Consensus Sleep Diary—Carney et al
ma LP, Sanofi-Aventis, and Somaxon. Dr. Edinger has research 8. Smith MT, Perlis ML, Park A, et al. Comparative meta-analysis of phar-
support from Philips/Respironics and has consulted with Live macotherapy and behavior therapy for persistent insomnia. Am J Psychia-
try 2002;159:5-11.
to Sleep, Inc. (for less than $10,000 in fees). Dr. Krystal has 9. Bootzin RR, Nicassio PM. Behavioral treatments for insomnia. In: Hers-
received grants/research support from: Sanofi-Aventis, Cepha- en M, Eissler R, Miller P, eds. Progress in behavior modification. Vol 6.
lon, GlaxoSmithKline, Merck, Neurocrine, Pfizer, Sepracor/ New York: Academic Press; 1978:1-45.
Sunovion, Somaxon, Takeda, Transcept, Respironics, Neuro- 10. Bootzin RR, Engle-Friedman M. The assessment of insomnia. Behav As-
sess 1981;3:107-26.
gen, Evotec, Astellas, Abbott; and has served as a consultant 11. U S Department of Health and Human Services. Guidance for industry:
for: Abbott, Actelion, Arena, Astellas, Axiom, AstraZeneca, patient-reported outcome measures: use in medical product development
BMS, Cephalon, Eli Lilly, GlaxoSmithKline, Jazz, Johnson to support labeling claims, 2009.
and Johnson, King, Merck, Neurocrine, Neurogen, Novartis, 12. Revicki DA, Erickson PA, Sloan JA, et al. Interpreting and reporting re-
sults based on patient-reported outcomes. Value Health 2007;10:S116-24.
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